Naltrexone: Important Safety Information

What is Naltrexone?

Naltrexone is an FDA-approved prescription medication indicated for the treatment of alcohol dependence. It is used to help reduce the urge or desire to drink alcohol in people with alcohol use disorder. It may also be prescribed to support individuals who want to cut back on drinking. Naltrexone should be used as part of a complete treatment plan that may include counseling, therapy, and behavioral support.

Important Safety Information

Do not take naltrexone if you:

• Are currently dependent on opioids or are in opioid withdrawal

• Are using opioid-based pain medications (such as Percocet, Vicodin, Lortab, Oxycodone, codeine, tramadol, morphine, or hydrocodone)

• Are taking medications known as opioid agonists (such as Suboxone, buprenorphine, or methadone)

• Are using illicit opioids (such as heroin or fentanyl)

• Have acute hepatitis or liver failure

• Are allergic to naltrexone or any of its ingredients

Before starting naltrexone, tell your healthcare provider if you:

• Use opioid-containing medicines for pain, cough, or diarrhea

• Have liver problems or hepatitis

• Are pregnant, plan to become pregnant, or are breastfeeding

• Have kidney problems

• Are taking any other medications, vitamins, or supplements

Warnings and Precautions:

• Taking naltrexone if you are currently dependent on opioids can lead to sudden opioid withdrawal, which can be severe

• Using opioids after stopping naltrexone may increase the risk of overdose or death, even at lower doses than previously used

• Naltrexone may cause liver injury, especially at high doses. Tell your provider if you notice yellowing of your skin or eyes, dark urine, or stomach pain

• Naltrexone does not prevent or treat alcohol withdrawal symptoms

Common side effects may include:

• Nausea

• Headache

• Dizziness

• Fatigue or sleep problems

• Anxiety or irritability

• Joint or muscle pain

If you experience severe side effects, signs of liver problems, or allergic reactions (rash, swelling, trouble breathing), stop taking naltrexone and seek medical help right away

Additional Information

• Always take naltrexone as prescribed by your healthcare provider

• Avoid taking opioids or opioid-containing medicines while on naltrexone

• Do not start or stop any medications without consulting your clinician

• Discuss any side effects or concerns with your healthcare provider

How to Report Side Effects

In addition to contacting your healthcare provider, you may report side effects to the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.

Prescribing Information

For complete prescribing information, please refer to the official FDA label:
Access the full Prescribing Information and Medication Guide (PDF)

Disclosure

Naltrexone is prescribed through Oar Health by licensed clinicians who determine whether it is appropriate for each patient. Oar Health does not manufacture medication; prescriptions are fulfilled through licensed U.S. pharmacies.